Primary Device ID | 20722355001122 |
NIH Device Record Key | a363ddb9-e987-4e76-b061-cff791c690e4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | hema-screen |
Version Model Number | HSDV-8 |
Company DUNS | 119214195 |
Company Name | Immunostics Company, Inc |
Device Count | 8 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10722355001125 [Primary] |
GS1 | 20722355001122 [Package] Contains: 10722355001125 Package: Case of 10 [10 Units] In Commercial Distribution |
GS1 | 80722355001124 [Unit of Use] |
KHE | REAGENT, OCCULT BLOOD |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2025-03-31 |
Device Publish Date | 2016-09-23 |
10722355002818 | Fecal Occult Blood IVD, Guaiac |
20722355001047 | Fecal Occult Blood IVD, Guaiac |
20722355001030 | Fecal Occult Blood IVD, Guaiac |
20722355001023 | Fecal Occult Blood IVD, Guaiac |
50722355001017 | Fecal Occult Blood IVD, Guaiac |
20722355001009 | Fecal Occult Blood IVD, Guaiac |
20722355001122 | Fecal Occult Blood Reagent, Guaiac |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() HEMA-SCREEN 76167666 2506476 Live/Registered |
STANBIO LABORATORY 2000-11-20 |
![]() HEMA-SCREEN 75392219 not registered Dead/Abandoned |
IMMUNOSTICS, INC. 1997-11-18 |
![]() HEMA-SCREEN 74053099 not registered Dead/Abandoned |
IMMUNOSTICS CO., INC. 1990-04-26 |